MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES HYSTEROFIBERSCOPE

Model Number	HYF-XP
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, during reprocessing, the oes hysterofiberscope tested positive for 2 colony forming units (cfus) of filamentous fungus on (b)(6) 2023.The device was retested on (b)(6) 2023 and found 2 colony forming units (cfus) of sphingomonas paucimobilis.All channels were sampled.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The customer provided the cleaning, disinfection, and sterilization process.The scope was quarantined after the positive culture was observed and stored at 25 degrees c.The scope was reprocessed twice before sampling and not used in any procedures while pending results.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The hygiene microbiological investigation results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device evaluation found the insertion part of the connecting tube was deformed, and the insertion part of the distal end of the biopsy channel forceps movement failed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The instruction manual of hyf-xp describes the reprocessing methods in the following chapters: chapter "compatible reprocessing methods and chemical agents".Chapter "cleaning, disinfection, and sterilization procedures".Olympus will continue to monitor field performance for this device.

• Brand Name: OES HYSTEROFIBERSCOPE
• Common Device Name: HYSTEROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17329606
• Report Number: 3002808148-2023-07155
• Device Sequence Number: 5510314
• Product Code: HIH
• UDI-Device Identifier: 04953170340178
• UDI-Public: 04953170340178
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K891451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HYF-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown